AI-enabled
Regulatory Monitoring

AI-enabled
Regulatory Monitoring

AI-enabled
Regulatory Monitoring

We build your central
regulatory intelligence hub.

We build your central
regulatory intelligence hub.

We build your central
regulatory intelligence hub.

Trusted by over 100+ MedTech manufacturers, including

Trusted by over 100+ MedTech manufacturers, including

One Platform. Worldwide Coverage.

Monitor all your relevant standards, regulations, and guidances in one tool.

Built to accelerate your

literature research

Standards, Guidances & Regulations

Standards, Guidances & Regulations

Monitored for the MedTech industry globally, with no limitations.

Monitored for the MedTech industry globally, with no limitations.

Worldwide

Be certain that no regulatory changes are missed.

Be certain that no regulatory
changes are missed.

What Flinn Can
Do For You

MONITORING

MONITORING

Monitor all your normative documents.

Monitor all your normative documents.

Immediately see when a new version was released.

Filter smartly through using various parameters (e.g., your assigned devices).

ASSESSMENT

ASSESSMENT

Efficient AI-assisted impact assessment of every change.

Efficient AI-assisted impact assessment of every change.

Screen changes smoothly with a detailed gap analysis.


Receive suggestions on relevancy of the change specifically for medical device manufacturers.

Our time-saving features

Built to accelerate your change monitoring process

Built to accelerate your

literature research

Change Descriptions and Impact Assessment

Be informed if elements change and receive a compact overview of changes and potential impacts.

Full Coverage of International and National Standards

Standards are monitored in their global, european and national version to keep track of geographic changes.

Complete Monitoring of Guidance Documents

Get notified about new IMDRF, GHTF, MEDDEV, and MDCG documents.

Broad List of Details

Have a complete summary of each element, such as date of publication, current activity status, geographical application and much more.

Recommendation of New Elements

Stay ahead by getting medical device industry specific new standards and regulations that might be of interest.

Broad List of Details

Have a complete summary of each element, such as date of publication, current activity status, geographical application and much more.

Recommendation of New Elements

Stay ahead by getting medical device industry specific new standards and regulations that might be of interest.

Change Descriptions & Impact Assessment

Full Coverage of International & National Standards

Complete Monitoring of Guidance Documents

Broad List of Details

Recommendation of New Elements

Change Descriptions & Impact Assessment

Full Coverage of International & National Standards

Complete Monitoring of Guidance Documents

Broad List of Details

Recommendation of New Elements

How accurate is Flinn?

How accurate
is Flinn?

We build our software to meet the accuracy standards of safety-critical, regulated environments.
We secure highest accuracy by:
Validating and releasing features carefully
Validating and releasing features carefully
Benchmarking models for every task
Benchmarking models for every task
Training on real-world medical data
Training on real-world medical data

Validating and releasing features carefully

New AI features are launched in isolated environments, reviewed by experts, tested with real users, and only integrated into live workflows once proven effective and trustworthy.

Benchmarking models

for every task

We benchmark state-of-the-art LLMs (e.g., OpenAI, Claude, and LLaMA) to select the best model for each use case. Performance is continuously monitored and models are updated to ensure high and consistent accuracy.

Training on real-world medical data

Our models are trained and validated on curated datasets built with medical experts, using real data from medical devices to ensure clinically relevant and reliable outputs.

Let us show you

Let our experts walk you through Flinn’s software, showcasing the features that matter most for your use case.

Let us show you

Let our experts walk you through Flinn’s software, showcasing the features that matter most for your use case.

Let us show you

Let our experts walk you through Flinn’s software, showcasing the features that matter most
for your use case.
Bastian Krapinger-Rüther

© 2025, 1BillionLives GmbH,

All Rights Reserved

© 2025, 1BillionLives GmbH,

All Rights Reserved

© 2025, 1BillionLives GmbH,

All Rights Reserved